clinical evidence of tavr in intermediate risk patients: lessons … · corevalve high-risk: 3-year...
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Clinical evidence of TAVR in intermediate risk
patients: Lessons from clinical trials
Andreas Baumbach, M.D.
Queen Mary University and Barts Heart Centre, London
Yale School of Medicine, New Haven, CT
@
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Disclosures
• Speaker Fees: AZ, The Medicines Company, Abbott Vascular, KSH, Microport
• Advisory Boards: Abiomed, Abott Vascular, KSH, Microport, Medicines Company, Sinomed
• Institutional Research Support: Medtronic, Abbott Vascular
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Trial Evidence
• Randomised controlled trials
– TAVI in inoperable patients
– TAVI in high risk patients
– TAVI in intermediate risk patients
• Registry data
• Upcoming trials and next questions
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WHAT IS INTERMEDIATE RISK ?
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Intermediate risk
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Intermediate risk
• Patients who are operable
• Absence of severe comorbidities
• Risk score in the medium/low range
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DATA
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TAVI vs Medical Rx: Inoperable Patients
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TAVI vs SAVR: High Risk Patients
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European sentinel registry
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TAVI 2002-2016: Devices with CE Mark Approval
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SURTAVI
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TAVR
SAVR
SURTAVI Trial: All Death or Disabling Stroke
0%
5%
10%
15%
20%
25%
30%
0 6 12 18 24
All-
Cau
se M
ort
alit
y o
r D
isab
ling
Stro
ke
Months Post-Procedure
796 674 555 407 241
864 755 612 456 272
24 Months
TAVR SAVR
12.6% 14.0%
N=1746
Reardon M. NEJM 2016
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Rationale for TAVI in Low Risk Patients
Bonow et al. Lancet 2016
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TAVI in Low Risk Patients: Ongoing Trials
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To be continued